I'm not going to steal any of this one... Click over here to watch and read.

http://www.rsc.org/chemistryworld/News/2009/January/29010901.asp

EPA's chemical evaluation process 'high-risk'

29 January 2009

The US government's 32-year-old law regulating chemical safety needs a complete overhaul, according to Congress' investigative arm, known as the Government Accountability Office (GAO). In a 22 January report, GAO says comprehensive reform of the Toxic Substances Control Act (TSCA) - which is administered by the US Environmental Protection Agency (EPA) - should be a top priority. 

In GAO's 'High Risk' priority document - which identifies the government programmes, policies, and operations most in need of fixing - the office concludes that EPA's 'inadequate progress' in assessing toxic chemicals significantly hampers its ability to protect human health and the environment. 

'The Environmental Protection Agency lacks adequate scientific information on the toxicity of many chemicals that may be found in the environment - as well as on tens of thousands of chemicals used commercially in the United States,' the report concludes. GAO also criticises EPA for failing to routinely assess the risks of the roughly 80,000 industrial chemicals that are already in use in the US.

In addition, the report says action is needed to streamline and increase the transparency of EPA's Integrated Risk Information System (IRIS), a compilation of reports on specific substances and their potential to cause human health effects. GAO notes thatsome of the chemicals most likely to cause significant health problems are among the IRIS assessments that have taken the longest to complete. EPA's assessment of dioxin, for example, has been ongoing for 18 years. 

Industry concerns

The American Chemistry Council (ACC), the major trade association for US chemical companies, agrees that improving the quality of EPA's chemical risk assessments is important. 'ACC has been concerned for some time that the IRIS process was moving more slowly than desired, not only in output, but also with incorporating scientific advances in risk assessment,' the group states.

Paul Anastas, the director of Yale University's Center for Green Chemistry and Green Engineering, says an overhaul of TSCA is long overdue. 'A chemicals statue should not facilitate endless review, analysis and characterisation of problems, rather it should facilitate moving toward new classes of substances of less risk to human health and the environment,' he tells Chemistry World. 'Right now, TSCA facilitates paralysis by analysis.'

The GAO report points out that the European Union's Registration, Evaluation and Authorization of Chemicals (Reach) legislation requires companies to provide safety data and risk assessments on the chemicals they produce, but TSCA generally places the onus on EPA to obtain such data. This requirement is costly and time-consuming because it compels EPA to demonstrate that certain health or environmental risks are likely before the agency can require companies to further test their chemicals. 

'Without greater attention to EPA's efforts to assess toxic chemicals, the nation lacks assurance that human health and the environment are adequately protected,' GAO warns.

Political power

The new Obama administration does appear to have the political will to rework EPA's system for assessing chemicals. Throughout his campaign, Obama repeatedly discussed the importance of protecting the public and environment from toxic substances. The agency's new administrator - chemical engineer Lisa Jackson - recently listed revising and strengthening EPA's chemical risk management as one of her top priorities.

There is also an expectation on Capitol Hill that members of the Senate Environment and Public Works Committee will use the GAO report to expedite EPA reform in areas like TSCA.

But even if the White House and new Congress actively pursue modifications to TSCA, such efforts will likely face major opposition from chemical companies that have a vested interest in avoiding extra, expensive testing.

'It isn't just one or two studies that will help define the toxicology and exposure of a chemical - it will be many,' says Larry Turner, an ecotoxicologist who worked for EPA for nearly 30 years and served in the agency's toxic substances group during that time. 'This gets very expensive for the chemical companies, and for EPA as well because this extra data has to be processed and assessed,' he adds.

For its part, EPA would not comment on the GAO recommendations. The agency did note, however, that it has a newly confirmed administrator and will review the GAO report and 'respond accordingly'.

Rebecca Trager, US correspondent for Research Day USA

Read www.ewg.org for more on PFOA.

http://www.bloomberg.com/apps/news?pid=20601124&sid=awvWoTZ_nLN8&refer=home

Chemicals in Skin Cream, Floss May Lower Fertility, Study Says

By Chantal Britt

Jan. 29 (Bloomberg) -- Chemicals found in a wide range of household products, including non-stick pans and skin creams, may make it harder for some women to get pregnant, a new study shows.

Researchers led by Chunyuan Fei, from the University of California in Los Angeles, studied data on 1,240 women and found those with higher levels of fluorine-containing compounds in their blood took longer to conceive. The study is published in next month’s issue of the medical journal Human Reproduction.

The compounds, known as perfluorinated chemicals or PFCs, may interfere with hormones that are involved in reproduction, Fei wrote in the study. The father’s sperm quality may also be affected by the chemicals and contribute to the problem, he said.

“Animal studies have shown that these chemicals may have a variety of toxic effects on the liver, immune system and developmental and reproductive organs,” Fei said.

The researchers are the first to study the link between infertility and the presence of chemicals such as perfluorooctanoic acid and perfluorooctane sulfonate in the blood. Fertility rates have declined in developed countries in recent decades. In the U.S., 8 percent of women of child-bearing age have had an infertility-related medical visit, according to the Centers for Disease Control and Prevention.

PFCs are used to make textiles and leather resistant to water, dirt or oil. They are also found in personal care products such as nail polish, dental floss or facial moisturizer. The chemicals resist breakdown and tend to persist in the environment and in the body for decades.

3M Co., which used perfluorooctanoic acid in the fabric protector Scotchgard, funded the study and its toxicology laboratories performed the analyses. After 3M discovered the chemicals’ toxic properties in 2001, it stopped using PFCs.

To contact the reporter on this story: Chantal Britt at cbritt@bloomberg.net Last Updated: January 29, 2009 04:05 EST

The shame of it is that there is a ton of real pollution out there, and we're wasting time and money with this horse malarkey.

The Amazing Story Behind the Global Warming Scam

By John Coleman
January 28, 2009

The key players are now all in place in Washington and in state governments across America to officially label carbon dioxide as a pollutant and enact laws that tax we citizens for our carbon footprints. Only two details stand in the way, the faltering economic times and a dramatic turn toward a colder climate. The last two bitter winters have lead to a rise in public awareness that CO2 is not a pollutant and is not a significant greenhouse gas that is triggering runaway global warming.

How did we ever get to this point where bad science is driving big government we have to struggle so to stop it?

The story begins with an Oceanographer named Roger Revelle. He served with the Navy in World War II. After the war he became the Director of the Scripps Oceanographic Institute in La Jolla in San Diego, California. Revelle saw the opportunity to obtain major funding from the Navy for doing measurements and research on the ocean around the Pacific Atolls where the US military was conducting atomic bomb tests. He greatly expanded the Institute's areas of interest and among others hired Hans Suess, a noted Chemist from the University of Chicago, who was very interested in the traces of carbon in the environment from the burning of fossil fuels. Revelle tagged on to Suess studies and co-authored a paper with him in 1957. The paper raises the possibility that the carbon dioxide might be creating a greenhouse effect and causing atmospheric warming. It seems to be a plea for funding for more studies. Funding, frankly, is where Revelle's mind was most of the time.

Next Revelle hired a Geochemist named David Keeling to devise a way to measure the atmospheric content of Carbon dioxide. In 1960 Keeling published his first paper showing the increase in carbon dioxide in the atmosphere and linking the increase to the burning of fossil fuels.

These two research papers became the bedrock of the science of global warming, even though they offered no proof that carbon dioxide was in fact a greenhouse gas. In addition they failed to explain how this trace gas, only a tiny fraction of the atmosphere, could have any significant impact on temperatures.

Now let me take you back to the1950s when this was going on. Our cities were entrapped in a pall of pollution from the crude internal combustion engines that powered cars and trucks back then and from the uncontrolled emissions from power plants and factories. Cars and factories and power plants were filling the air with all sorts of pollutants. There was a valid and serious concern about the health consequences of this pollution and a strong environmental movement was developing to demand action. Government accepted this challenge and new environmental standards were set. Scientists and engineers came to the rescue. New reformulated fuels were developed for cars, as were new high tech, computer controlled engines and catalytic converters. By the mid seventies cars were no longer big time polluters, emitting only some carbon dioxide and water vapor from their tail pipes. Likewise, new fuel processing and smoke stack scrubbers were added to industrial and power plants and their emissions were greatly reduced, as well.

But an environmental movement had been established and its funding and very existence depended on having a continuing crisis issue. So the research papers from Scripps came at just the right moment. And, with them came the birth of an issue; man-made global warming from the carbon dioxide from the burning of fossil fuels.

Revelle and Keeling used this new alarmism to keep their funding growing. Other researchers with environmental motivations and a hunger for funding saw this developing and climbed aboard as well. The research grants began to flow and alarming hypothesis began to show up everywhere.

The Keeling curve showed a steady rise in CO2 in atmosphere during the period since oil and coal were discovered and used by man. As of today, carbon dioxide has increased from 215 to 385 parts per million. But, despite the increases, it is still only a trace gas in the atmosphere. While the increase is real, the percentage of the atmosphere that is CO2 remains tiny, about .41 hundredths of one percent.

Several hypothesis emerged in the 70s and 80s about how this tiny atmospheric component of CO2 might cause a significant warming. But they remained unproven. Years have passed and the scientists kept reaching out for evidence of the warming and proof of their theories. And, the money and environmental claims kept on building up.

Back in the 1960s, this global warming research came to the attention of a Canadian born United Nation's bureaucrat named Maurice Strong. He was looking for issues he could use to fulfill his dream of one-world government. Strong organized a World Earth Day event in Stockholm, Sweden in 1970. From this he developed a committee of scientists, environmentalists and political operatives from the UN to continue a series of meeting.

Strong developed the concept that the UN could demand payments from the advanced nations for the climatic damage from their burning of fossil fuels to benefit the underdeveloped nations, a sort of CO2 tax that would be the funding for his one-world government. But, he needed more scientific evidence to support his primary thesis. So Strong championed the establishment of the United Nation's Intergovernmental Panel on Climate Change. This was not a pure climate study scientific organization, as we have been lead to believe. It was an organization of one-world government UN bureaucrats, environmental activists and environmentalist scientists who craved the UN funding so they could produce the science they needed to stop the burning of fossil fuels. Over the last 25 years they have been very effective. Hundreds of scientific papers, four major international meetings and reams of news stories about climatic Armageddon later, the UN IPCC has made its points to the satisfaction of most and even shared a Nobel Peace Prize with Al Gore.

At the same time, that Maurice Strong was busy at the UN, things were getting a bit out of hand for the man who is now called the grandfather of global warming, Roger Revelle. He had been very politically active in the late 1950's as he worked to have the University of California locate a San Diego campus adjacent to Scripps Institute in La Jolla. He won that major war, but lost an all important battle afterward when he was passed over in the selection of the first Chancellor of the new campus.

He left Scripps finally in 1963 and moved to Harvard University to establish a Center for Population Studies. It was there that Revelle inspired one of his students to become a major global warming activist. This student would say later, "It felt like such a privilege to be able to hear about the readouts from some of those measurements in a group of no more than a dozen undergraduates. Here was this teacher presenting something not years old but fresh out of the lab, with profound implications for our future!" The student described him as "a wonderful, visionary professor" who was "one of the first people in the academic community to sound the alarm on global warming," That student was Al Gore. He thought of Dr. Revelle as his mentor and referred to him frequently, relaying his experiences as a student in his book Earth in the Balance, published in 1992.

So there it is, Roger Revelle was indeed the grandfather of global warming. His work had laid the foundation for the UN IPCC, provided the anti-fossil fuel ammunition to the environmental movement and sent Al Gore on his road to his books, his movie, his Nobel Peace Prize and a hundred million dollars from the carbon credits business.

What happened next is amazing. The global warming frenzy was becoming the cause celeb of the media. After all the media is mostly liberal, loves Al Gore, loves to warn us of impending disasters and tell us "the sky is falling, the sky is falling". The politicians and the environmentalist loved it, too.

But the tide was turning with Roger Revelle. He was forced out at Harvard at 65 and returned to California and a semi retirement position at UCSD. There he had time to rethink Carbon Dioxide and the greenhouse effect. The man who had inspired Al Gore and given the UN the basic research it needed to launch its Intergovernmental Panel on Climate Change was having second thoughts. In 1988 he wrote two cautionary letters to members of Congress. He wrote, "My own personal belief is that we should wait another 10 or 20 years to really be convinced that the greenhouse effect is going to be important for human beings, in both positive and negative ways." He added, "…we should be careful not to arouse too much alarm until the rate and amount of warming becomes clearer."

And in 1991 Revelle teamed up with Chauncey Starr, founding director of the Electric Power Research Institute and Fred Singer, the first director of the U.S. Weather Satellite Service, to write an article for Cosmos magazine. They urged more research and begged scientists and governments not to move too fast to curb greenhouse CO2 emissions because the true impact of carbon dioxide was not at all certain and curbing the use of fossil fuels could have a huge negative impact on the economy and jobs and our standard of living. I have discussed this collaboration with Dr. Singer. He assures me that Revelle was considerably more certain than he was at the time that carbon dioxide was not a problem.

Did Roger Revelle attend the Summer enclave at the Bohemian Grove in Northern California in the Summer of 1990 while working on that article? Did he deliver a lakeside speech there to the assembled movers and shakers from Washington and Wall Street in which he apologized for sending the UN IPCC and Al Gore onto this wild goose chase about global warming? Did he say that the key scientific conjecture of his lifetime had turned out wrong? The answer to those questions is, "I think so, but I do not know it for certain". I have not managed to get it confirmed as of this moment. It's a little like Las Vegas; what is said at the Bohemian Grove stays at the Bohemian Grove. There are no transcripts or recordings and people who attend are encouraged not to talk. Yet, the topic is so important, that some people have shared with me on an informal basis.

Roger Revelle died of a heart attack three months after the Cosmos story was printed. Oh, how I wish he were still alive today. He might be able to stop this scientific silliness and end the global warming scam.

Al Gore has dismissed Roger Revelle's Mea culpa as the actions of senile old man. And, the next year, while running for Vice President, he said the science behind global warming is settled and there will be no more debate, From 1992 until today, he and his cohorts have refused to debate global warming and when ask about we skeptics they simply insult us and call us names.

So today we have the acceptance of carbon dioxide as the culprit of global warming. It is concluded that when we burn fossil fuels we are leaving a dastardly carbon footprint which we must pay Al Gore or the environmentalists to offset. Our governments on all levels are considering taxing the use of fossil fuels. The Federal Environmental Protection Agency is on the verge of naming CO2 as a pollutant and strictly regulating its use to protect our climate. The new President and the US congress are on board. Many state governments are moving on the same course.

We are already suffering from this CO2 silliness in many ways. Our energy policy has been strictly hobbled by no drilling and no new refineries for decades. We pay for the shortage this has created every time we buy gas. On top of that the whole thing about corn based ethanol costs us millions of tax dollars in subsidies. That also has driven up food prices. And, all of this is a long way from over.

And, I am totally convinced there is no scientific basis for any of it.

Global Warming. It is the hoax. It is bad science. It is a high jacking of public policy. It is no joke. It is the greatest scam in history.

John Coleman
1-29-09

http://www.bloomberg.com/apps/news?pid=newsarchive&sid=a5NUWNMLWKhE

AstraZeneca Is Asked to Expand Warning, Lawyer Says (Update3)

By Margaret Cronin Fisk and Jef Feeley

Jan. 27 (Bloomberg) -- AstraZeneca Plc was asked by U.S. regulators to strengthen warnings on its antipsychotic drug Seroquel about potential side effects that can lead to diabetes, according to court documents.

The U.S. Food and Drug Administration wants AstraZeneca, the U.K.’s second-largest drugmaker, to highlight on Seroquel’s warning label that some users experienced “significant weight gain,” lawyers for consumers suing the company said in a court filing yesterday. The first trial over claims that Seroquel caused diabetes is set to begin Feb. 2 in Orlando, Florida.

Letters sent by regulators to the London-based company last month “reveal FDA directives to AstraZeneca” to expand Seroquel’s warning label, Richard Laminack, a lawyer for two former Seroquel users, said in the federal court filing.

AstraZeneca faces about 9,000 lawsuits with more than 15,000 plaintiffs in the U.S. over claims that Seroquel causes diabetes and other health problems. Seroquel, which generated sales of $4.03 billion in 2007, is the company’s second-biggest seller after the ulcer treatment Nexium.

“This warning will reduce the attractiveness of using this drug, given the risk of developing a serious condition,” said Navid Malik, an analyst at London-based Matrix Corporate Capital LLP. He doesn’t have a rating on the stock.

AstraZeneca Shares

AstraZeneca fell 115 pence, or 3.9 percent, to 2,832 pence in London trading, the biggest drop in two months. The company’s American depositary receipts, each representing one ordinary share, declined 83 cents, or 2 percent, to $39.99 in New York Stock Exchange composite trading.

Johnson & Johnson, maker of the rival antipsychotic Risperdal, rose 99 cents, or 1.8 percent, to $57.54. Eli Lilly & Co., maker of the antipsychotic Zyprexa, rose $1.04, or 2.8 percent, to $38.61.

Seroquel’s label has “always provided accurate and appropriate information and warnings,” Tony Jewell, a spokesman for AstraZeneca in Wilmington, Delaware, said in an e-mailed statement. “We continue to work with the FDA to share accurate information with the public as more scientific data becomes available about the medicine.”

Jewell declined to comment on whether the FDA had requested stronger Seroquel warnings and said communications with the agency were confidential.

Weight Gain

Studies linking Seroquel, Zyprexa and similar antipsychotic treatments to weight gain and diabetes prompted the FDA to require that all makers of such medicines warn doctors about risks in 2003 and 2004.

Obesity is a known risk factor for type-two diabetes, a metabolic disorder in which the body stops responding to insulin properly, according to the Centers for Disease Control and Prevention in Atlanta.

Evidence uncovered in pre-trial exchanges of information shows that FDA officials advised AstraZeneca executives in letters of Dec. 18 and Dec. 22 that the “significant weight gain” reference should be added to the label’s “warnings and precautions section,” according to Laminack’s filing. It had been listed under “vital signs” on the label, the lawyer said.

The FDA also wants “data for Seroquel-induced weight change and glucose changes” moved up into the label’s warning section, according to the filing.

Karen Riley, an FDA spokeswoman, said she couldn’t immediately comment on whether the agency had asked AstraZeneca to toughen Seroquel’s warning.

Expert Witnesses

The FDA’s calls for stronger warnings “mirror” the contentions of consumers’ expert witnesses, who are seeking to testify in Linda Guinn’s trial, Laminack said in the filing. U.S. District Judge Anne Conway hasn’t ruled whether jurors will be allowed to hear those experts.

“Seroquel and Zyprexa are among the worst offenders affecting hazardous weight gain and glucose changes,” Laminack claimed in the filing.

Lilly agreed to pay at least $1.2 billion to settle lawsuits filed by about 31,000 patients who used Zyprexa. The Indianapolis-based company said this month it would pay an additional $1.42 billion to resolve claims by state and federal officials that it marketed the drug for unapproved uses. Lilly also agreed to plead guilty to a criminal charge.

AstraZeneca officials have said they will fight each Seroquel case and don’t plan to settle.

The drugmaker gave the FDA letters to plaintiffs on Jan. 21, Laminack said in the filing. Guinn’s lawyers asked Conway to punish AstraZeneca for failing to hand over the letters promptly by delaying the Feb. 2 trial for a month, giving them more time to gather information about the FDA’s contacts with the company over the label.

AstraZeneca should be sanctioned for “efforts to hide or delay the truth” in the Seroquel cases, the consumers’ lawyers said in court papers.

The case is Guinn v. Astra USA Inc., 07-10291-ACC, U.S. District Court, Middle District of Florida (Orlando).

To contact the reporters on this story: Margaret Cronin Fisk in Southfield, Michigan, at mcfisk@bloomberg.net; Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net. Last Updated: January 27, 2009 16:22 EST

http://www.nytimes.com/2009/01/28/us/28fda.html?_r=1

Dissidents at F.D.A. Complain of Inquiry

Nine dissident scientists at the Food and Drug Administration who say they were forced to approve high-risk medical devices sent a letter to President Obama on Monday stating that agency officials might have made them the targets of a criminal investigation into their complaints.

“It has been brought to our attention that F.D.A. management may have just recently ordered the F.D.A. Office of Criminal Investigations (O.C.I.) to investigate us rather than the managers who have engaged in wrongdoing!” states the letter, which was provided to The New York Times. “It is an outrage that our own agency would step up the retaliation to such a level because we have reported their wrongdoing to the United States Congress.”

Heidi Rebello, an F.D.A. spokeswoman, said she could neither confirm nor deny the existence of a criminal investigation.

The letter is the latest escalation in a highly unusual internal battle that has been simmering for nearly a year within the agency’s device division. The nine scientists have banded together and charged that agency officials have acted illegally and that patients are routinely put at risk from high-risk medical devices that are approved for sale even though manufacturers have never proved that the products are either safe or effective.

The scientists complained in May to Dr. Andrew C. von Eschenbach, who was then the F.D.A. commissioner, and the agency began an internal review that continues. Dissatisfied with the pace and results of that review, the scientists wrote a letter to Congress in October pleading for an investigation, and the House Committee on Energy and Commerce announced in November that it would begin one, which also continues.

Three weeks ago, the scientists wrote a similar letter to the president-elect’s transition team. And on Monday, the scientists wrote another letter to President Obama.

Confidential agency documents, which include both e-mail messages and medical reviews detailing the internal dispute were provided to The Times.

It can be a crime for agency employees to reveal documents or information considered confidential by companies seeking agency approval for medical products.

Some of the scientists’ claims about the agency’s device approval process were echoed in a report released two weeks ago by the Government Accountability Office that was also critical of the agency’s device center.

Created in 1976, the F.D.A.’s process for approving devices divides the products into three classes and three levels of scrutiny. Tongue depressors, reading glasses, forceps and similar products are called Class I devices and are largely exempt from agency reviews. Mercury thermometers are among Class II devices, and most get quick reviews. Class III devices include pacemakers and replacement heart valves, and Congress mandated that manufacturers of Class III devices must prove through extensive testing that their products are safe and effective.

But the accountability investigators found that the agency still allowed manufacturers of most Class III devices to gain approval without conducting extensive testing. Part of the reason may be that some Class III devices should be reclassified as Class II devices, while other such devices simply should be tested more.

The agency has promised for years to fix its device approval process but cannot say when the fix will be completed.

Critics have long bemoaned the agency’s device approval process, which allows most devices to be approved with minimal testing. Manufacturers say the agency is already overly restrictive.

With internal, Congressional and perhaps now criminal investigations swirling about the agency’s device division, the controversy regarding device approvals appears only to be worsening. In Monday’s letter to Mr. Obama, the nine scientists provided a detailed list of laws that they claim agency officials have violated.“We are asking for your immediate intervention,” the letter to Mr. Obama stated.

Check out the Environmental Working Group's coverage of the FDA BPA snafu--how the FDA believed the American Chemistry Council when it insisted that this biologically persistent, carcinogenic endocrine disruptor was safe, despite numerous studies showing the exact opposite. Then read this article and ask yourself if there is any part of the FDA that hasn't been bought by industry.

http://uk.reuters.com/article/scienceNewsMolt/idUKTRE50R0US20090128

Plastic chemical may stay in body longer: study

Not happy with convincing the CDC that teens are at high risk for meningitis, Big Pharma is preparing an infant meningitis vaccination, Novartis's Menveo, expected to be sent for FDA approval in 2011. Thirty-five shots by age six isn't enough, I guess...

Why, oh why, did Obama not pick Bobby Kennedy, Jr.? Oh, right, because Obama's under the thumb of industry, too.

http://www.alternet.org/water/122871/after_admitting_faults_at_hearing,_new_epa_head_starts_work/

After Admitting Faults at Hearing, New EPA Head Starts Work

By Joaquin Sapien, ProPublica. Posted January 26, 2009.

With little scrutiny or controversy, Lisa Jackson was confirmed by the Senate to head the Environmental Protection Agency after a confirmation hearing where criticisms of Jackson's tenure as head of the New Jersey Department of Environmental Protection were given short shrift.

In her first move as EPA chief, Jackson pledged to make science "the backbone for EPA programs." In a memo sent to EPA employees, Jackson said that reducing greenhouse gas emissions, managing chemical risks, cleaning up hazardous waste and protecting America's water would receive her personal attention.

As ProPublica reported, Jackson's approach to virtually all of these goals was criticized when she was head of the New Jersey's environmental department. In the run-up to her confirmation, Jackson's critics accused her of being cozy with industry, failing to act on a three-year-old recommendation to regulate perchlorate in drinking water, and not fulfilling a promise to fix the state's hazardous waste program.

Questions about these aspects of her record were only briefly addressed at her confirmation hearing. Sen. Barbara Boxer (D-CA), chair of the Environment and Public Works Committee, saved these questions for what she called a "lighting round" that took place in the final minutes of Jackson's confirmation.

During the "lighting round," Jackson for the first time acknowledged there was a delay between her agency's discovery that a day care center was built inside an abandoned thermometer factory contaminated with mercury and her demand that the day care center be shutdown.

Jackson initially claimed in a 2006 press release that as soon as she found out the Kiddie Kollege day care center was contaminated with mercury, "inspectors moved in, took samples and shut it down."

In the hearing, Jackson said that in fact, months passed before her department shut down the day care center because the department waited for mercury test results to come back. "I know that in hindsight we all wish things had turned out differently, and that's really what I would say to the parents," said Jackson.

Next, Jackson defended her record on perchlorate, a chemical in rocket fuel that was found in six out of 123 public drinking water wells in New Jersey. Each well served at least 10,000 people. Studies link perchlorate to thyroid damage that can slow brain development in children.

In October 2005, New Jersey was urged to regulate the chemical by a panel of state scientists, environmental activists and industry leaders. Three years later, the DEP still hasn't completed a draft of the rule.

In the hearing Jackson admitted the standard was late, but assured the Senate her agency was closely monitoring perchlorate levels and the proposed rule should be out by the end of the month.

Two weeks ago the Bush administration's EPA announced it would delay its decision on whether to set a national drinking water standard for perchlorate until it receives advice from the National Academy of Sciences, effectively punting the decision to Jackson.

Boxer asked Jackson if she would "commit to immediately review this failure to establish a drinking water standard for perchlorate and act to address the threat to pregnant women and children caused by this dangerous toxin?"

Jackson promised that she would.

As NJDEP administrator, Jackson also came under fire for her approach toward toxic waste sites scattered throughout New Jersey.

Jackson was accused of failing to prioritize New Jersey's 16,000 sites, a promise she made shortly after she became head of the department in 2006. In the hearing, Jackson said the department's development of the ranking system is "not quite done yet, so it's late, but it's late because it relies on GPS technology, and for the first time ever, site-specific pollution data."

Jackson also supported a controversial proposal backed by New Jersey Gov. Jon Corzine to outsource the department's cleanup efforts to consultants. The policy could result in cleanups being conducted by groups that also work for the companies responsible for the contaminated sites.

Boxer, an ardent critic of the Bush administration's handling of the federal government's Superfund program to clean up toxic waste, questioned Jackson's support of the Corzine proposal. But Jackson said she wouldn't use private consultants at federal Superfund sites because "of the differences in the way New Jersey manages its program versus the federal program."

Jackson's approach toward one contaminated site in particular created quite a stir in New Jersey. At issue were wide swaths of valuable land laden with chromium, a carcinogenic chemical.

In one of her first moves as the head of New Jersey's environment department, Jackson lifted a moratorium on residential development on chromium contaminated land, and tightened New Jersey's chromium standard.

But New Jersey department scientist, Zoe Kelman, protested that decision, saying that it was premature because a more comprehensive study on chromium was due to be completed by the National Toxicology Program later that year. When that report came out, Jackson did not revisit New Jersey's chromium standard or her decision to lift the moratorium on development.

Kelman, who quit the department out of frustration, says that Jackson "ignored" a letter she wrote about how a protective cap made out of synthetic materials and soil would not sufficiently control chromium-laden waste in Jersey City.

While Jackson was not specifically asked about her history on chromium at her confirmation hearing, Sen. Boxer did ask whether Jackson would regulate the chemical in drinking water as head of the EPA. Again, Jackson assured the senator that she would abide by her request.

The EPA's ailing chemical risk assessment program may be one of the more daunting challenges that Jackson will face at the EPA.

Last week, the Government Accountability Office released a report adding the program to its list of 30 "high-risk" federal programs.

"EPA does not have sufficient chemical assessment information to determine whether it should establish controls to limit public exposure to many chemicals that may pose substantial health risks," the report said.

The only apparent snag in Jackson's confirmation was Sen. John Barasso's (R-WY) concerns about the division of labor between Jackson and Obama's appointed White House "climate czar," Carol Browner.

Barasso removed his hold on the confirmation after speaking to Browner and Jackson, clearing the way for her confirmation.

http://www.forbes.com/feeds/ap/2009/01/26/ap5964482.html

KV Pharmaceutical to recall most products

Associated Press, 01.26.09, 01:10 PM EST

Shares of KV Pharmaceutical plummeted to an all-time low Monday morning after the company said it would recall most of its products and halted its manufacturing and shipping operations.

The announcement followed two product recalls in November and December linked to oversize tablets, including painkillers and attention-deficit disorder drugs, which could deliver dangerously large doses.

The company said the exact terms of the latest voluntary recall are still in discussion with safety regulators at the Food and Drug Administration. The agency began investigating KV's manufacturing and quality control standards late last year.

In a regulatory filing Monday, the company warned investors that the FDA could pursue "judicial proceedings and criminal prosecution."

Shares of KV Pharmaceutical Co. (nyse: KVA - news - people ) plunged to a record low of 49 cents in morning trading, but recovered slightly to 58 cents, or down 74.1 percent, by early afternoon.

The company said the recall and suspension would have a significant impact on its financial position and warned that it could default on its credit agreement. At the end of 2008 the company owed $30 million on the agreement.

KV's board of directors also said it formed a special five-person committee to respond to charges that the company violated certain securities laws. The company faces class action lawsuits by investors as well as an informal inquiry by investigators at the Securities and Exchange Commission.

In an unrelated setback, the company said the FDA has delayed a decision on the company's experimental drug Gestiva, which is designed to prevent preterm birth. The company had previously told investors a decision would be issued by Jan. 25, but regulators have requested additional data on the drug.

http://online.wsj.com/article/SB123301757444517869.html?mod=dist_smartbrief

Mercury is a neurotoxin, and it's in high-fructose corn syrup.

http://www.forbes.com/feeds/hscout/2009/01/26/hscout623456.html

Study Finds High-Fructose Corn Syrup Contains Mercury

01.25.09, 08:00 PM EST

Half of batches tested positive, third of popular sweetened products showed traces

MONDAY, Jan. 26 (HealthDay News) -- Almost half of tested samples of commercial high-fructose corn syrup (HFCS) contained mercury, which was also found in nearly a third of 55 popular brand-name food and beverage products where HFCS is the first- or second-highest labeled ingredient, according to two new U.S. studies.

HFCS has replaced sugar as the sweetener in many beverages and foods such as breads, cereals, breakfast bars, lunch meats, yogurts, soups and condiments. On average, Americans consume about 12 teaspoons per day of HFCS, but teens and other high consumers can take in 80 percent more HFCS than average.

"Mercury is toxic in all its forms. Given how much high-fructose corn syrup is consumed by children, it could be a significant additional source of mercury never before considered. We are calling for immediate changes by industry and the [U.S. Food and Drug Administration] to help stop this avoidable mercury contamination of the food supply," said the Institute for Agriculture and Trade Policy's Dr. David Wallinga, a co-author of both studies.

In the first study, researchers found detectable levels of mercury in nine of 20 samples of commercial HFCS. The study was published in current issue of Environmental Health.

In the second study, the agriculture group found that nearly one in three of 55 brand-name foods contained mercury. The chemical was most common in HFCS-containing dairy products, dressings and condiments.

The use of mercury-contaminated caustic soda in the production of HFCS is common. The contamination occurs when mercury cells are used to produce caustic soda.

"The bad news is that nobody knows whether or not their soda or snack food contains HFCS made from ingredients like caustic soda contaminated with mercury. The good news is that mercury-free HFCS ingredients exist. Food companies just need a good push to only use those ingredients," Wallinga said.

More information

The U.S. Agency for Toxic Substances & Disease Registry has more about mercury and health.

The summer after my sophomore year at Harvard, I worked at a small public relations and marketing firm. One PR technique we used was sending press releases to news outlets, written exactly as we would like an article to appear. My boss, a savvy woman with a PhD from Penn, told me that a lot of times, reporters will be too lazy to research a story, and will need material, so they'll just reprint the whole press release, verbatim. Even the ones who do a bit of rewriting, she told me, will often pull the quotations directly from the press release as if they had interviewed the quotee themselves.

You may have read a couple of articles lately about how Massachusetts' new legislation (requiring doctors to disclose how much money they've been given by Big Pharma) is going to crush the hospitality industry in Massachusetts. Just keep in mind what my boss told me, particularly when you read the article on MedPageToday, with its right sidebar of Big Pharma ads. Who pays for this "publication"? Who provides its content? Who really wrote this article?

* * *
http://www.medpagetoday.com/PublicHealthPolicy/HealthPolicy/12567

Medical Group Pulls Meeting from Boston Over State Ethics Law

By John Gever, Senior Editor, MedPage Today
Published: January 22, 2009

BOSTON, Jan. 22 -- The American Academy of Allergy, Asthma and Immunology has cancelled plans to hold its 2015 annual meeting here, citing a strict new Massachusetts law regulating medical industry marketing.

The AAAAI interpreted the new law as forcing it to call off its lucrative continuing medical education activities because corporate participation would be disallowed.

The move by the AAAAI, which is based in Milwaukee, fulfilled the prediction by the state's hotel and hospitality industry that there would be unintended negative consequences of the new law.

Enacted last August, the law puts the state in the forefront of efforts to restrict the drug and device industries from overpromotion of their products to physicians and other providers.

It prohibits pharmaceutical and medical device companies from giving certain gifts to physicians, including paper pads, pens, coffee mugs and the like that are not educational in nature.

It also bans companies from providing free entertainment (such as sports tickets) and, under some circumstances, free meals. It requires that companies disclose all payments to physicians and other providers in excess of $50.

In addition, it disallows industry from sponsoring or supporting CME activities that do not meet standards for industry support set by the Accreditation Council for Continuing Medical Education (ACCME) or an equivalent body.

In a letter to the Boston Convention Marketing Center, which runs the facility at which the 2015 meeting was to have been held, AAAAI executive director Kay Whalen wrote that the group's board believed the law may effectively disallow CME credits for any part of the meeting.

"The board was also concerned about any additional legislation that may be passed prior to the 2015 meeting," the letter said. "Therefore, the board felt it may no longer be financially feasible to hold the annual meeting in Boston."

Whalen said the law's ban on gifts was also a concern, but the restrictions on CME were the main problem.

The Massachusetts law left the detailed interpretation to the state's public health department, which is now finalizing the specific rules.

The Massachusetts Medical Society was generally supportive of the draft regulations.

But, it said in a comment letter submitted to the department, their reporting requirements -- covering virtually all transactions worth more than $50 -- "may create a paperwork nightmare for industry which could lead to a de facto cessation of all distribution of samples or educational materials in Massachusetts."

The society said that if the reporting requirement covered educational materials, it could adversely affect its own CME programs as well as the New England Journal of Medicine, which it publishes.

Local hotels warned that the state could lose much of its medical convention business and urged delay in implementing the regulations until the full consequences could be analyzed.

A letter from the Massachusetts Lodging Association stated, "We are very concerned that should the companies that are subject to this law find any element of the new regulations onerous, Massachusetts hotels could lose significant business and, as a result, be forced to lay off staff. Similarly, municipal and state fiscal coffers, which rely heavily on such business, may be significantly impacted."

Drug and device companies also expressed unhappiness with the draft regulations, although they were more concerned about the reporting requirements for their interactions with physicians and other providers.

The regulations would require companies to disclose all payments "or other economic benefits" to providers of more than $50.

The state public health department has said in its public statements that the provision includes product samples, although the regulation itself does not mention them specifically.

Several drug companies and industry groups urged the department to declare that product samples are not included, because they benefit patients, not providers.

Some companies also said that disclosing the value of product samples would expose confidential pricing information.

Firms with operations in Massachusetts said many of the requirements would hinder their local activities and discourage other companies from locating there.

State officials and groups supporting the regulations said other states and perhaps the federal government would eventually follow Massachusetts' lead, so the state would no longer be at a disadvantage.

The comment period ended Jan. 19. The department is expected to issue final rules shortly.

The AAAAI has not yet identified a new location for its 2015 meeting. Whalen said many venues suitable for the event are already booked, and the group has to make an irrevocable final arrangement soon.

She said the group could reconsider Boston if the CME restrictions are relaxed in the final regulation. But it would have to be issued before AAAAI's annual meeting this year, scheduled for mid-March.

* * *

http://www.boston.com/news/local/massachusetts/articles/2009/01/24/new_drug_firm_limits_prompt_fears_of_falloff_in_medical_meetings_in_city/?page=2

New drug firm limits prompt fears of falloff in medical meetings in city

By Liz Kowalczyk Globe Staff / January 24, 2009


Boston's status as a popular destination for medical industry meetings - which generate tens of millions of dollars in revenue for hotels, restaurants, and the state - is at risk because of new regulations restricting financial relationships between pharmaceutical companies and doctors, according to industry executives.

The city hosted 2,500 medical and pharmaceutical company meetings in 2007 and 2008, attended by thousands of doctors and other clinicians; hotels earned $130 million from those meetings, while the state received about $16 million in tax payments, according to the Greater Boston Convention and Visitors Bureau. About 40 percent of the city's convention business is medical-related.

But now, with strict new regulations set to take effect July 1, some meeting sponsors are considering pulling out of Boston, said Patrick Moscaritolo, president of the convention bureau, who wants the state to delay im plementation of the law. At least two large medical conferences already have withdrawn.

One consumer group and a legislator who pushed for the law called the concerns far-fetched. Health Care for All, a Boston-based consumer advocacy group that is lobbying for even stricter regulation of industry interactions with physicians, said the medical groups are engaging in "fear-mongering" as a way to cast doubt on the new rules, which will be finalized within the next two months.

The American Academy of Allergy, Asthma and Immunology, however, wrote the convention bureau three weeks ago to say it has decided to relocate its 2015 annual meeting, with an estimated 8,000 doctors and other participants, which had been scheduled for the Boston Convention and Exposition Center. The group cancelled hundreds of rooms reserved for the meeting at the Westin Boston Waterfront. Conventions are planned years in advance.

Another group, the American Society of Gene Therapy, informed the convention bureau this week in writing that it has decided against booking its 2015 annual meeting in Boston because the regulations will "cripple the content and quality."

A third group, the Heart Rhythm Society, wrote to convention officials that it is reconsidering its commitment to hold five meetings in Boston between this year and 2021.

The groups said in the letters and in interviews with the Globe that one of their concerns is that the state's regulations, which establish a code of conduct for pharmaceutical company employees, will limit participation by drug company scientists in meetings and continuing medical education courses in Massachusetts.The state's rules say that continuing medical education courses, which doctors must take to keep their licenses, must comply with guidelines issued by the Accreditation Council for Continuing Medical Education. Kay Whalen, executive director of the allergy academy, and David Bodine, president of the gene therapy society, said this requirement is a major problem. Those guidelines don't allow presentations by drug company employees, and Whalen believes that Massachusetts intends to go further by saying drug company scientists cannot present research even for courses not for education credit.


"Quite a bit of cutting-edge research is done by pharmaceutical companies and scientists want to hear it," Whalen said. "Our reading of this law is we could not have those sessions at all."

"That's absolutely false," said Amy Whitcomb Slemmer, executive director of Health Care for All. "Of course company scientists can present. But having providers get education credit for that is not appropriate. It's an advertisement."

Public health officials said the regulations actually do allow company scientists to present at meetings in Massachusetts, but with caveats: The presentations must present information in an objective fashion and cannot simply be promotional talks for the company's products.

Drug companies participate heavily in medical meetings across the country in other ways as well, by paying for meals and subsidizing tuition and by hawking their products to doctors from rows of exhibits set up on convention floors. The new regulations will prohibit companies with booths from distributing free merchandise to Massachusetts doctors, state public health officials confirmed.

The regulations written by state Public Health Department staff are intended to implement a law passed by the Legislature last summer, which bans companies from providing gifts to physicians, limits when companies can pay for doctors' meals, and requires companies to publicly disclose payments to doctors over $50 for certain types of consulting and speaking engagements. The law aims to control costs by reining in unnecessary prescribing of expensive drugs and to make doctors' potential conflicts-of-interest transparent to the public.

The new rules also govern drug company conduct at scientific meetings, professional conferences, and continuing medical education courses in Massachusetts. They allow firms to sponsor such meetings, as they do now, but with restrictions: Companies cannot pay for attendees' personal expenses such as travel and lodging, or pay them to attend. Companies cannot pay for meals for specific groups of doctors in attendance, but conference organizers can use pharmaceutical company funds toward meal costs for everyone. And, drug companies cannot dictate to conference organizers on the presentations made to physicians.

Tom Lyons, Public Health Department spokesman, said the agency received 1,000 pages of comments on the proposed regulations from 120 groups and individuals - the most on any regulation in recent memory. "We will give due consideration to every comment that has been submitted, but we believe we have a very balanced regulation," he said.

On the opposite side, consumer groups and others are heavily lobbying health officials to tighten the rules. One criticism by Health Care for All and some legislators is that companies will not be required to disclose payments to doctors for research-related activities.

The Public Health Council plans to approve a final version of the rules in February or March.

"I don't buy that this will have any material effect on the convention business in Massachusetts," said Senator Mark C. Montigny, a New Bedford Democrat who has pushed for years to ban industry gift-giving. "But even if it does, I would say it's completely irrelevant. We're talking about rules to protect the public health here."Liz Kowalczyk can be reached at kowalczyk@globe.com

Judge for yourself.

In 2006, the FDA approves Gardasil, which is what parents give their daughters if they don't feel like talking to them about sex. It's a vaccine that can protect against four strains of the human papilloma virus, so you can see why vaccinated girls (as young as nine years old, with the ACIP recommending 11 or 12 as the target age) might think that they can have sex without a condom and face no consequences--particularly since their parents would clearly rather spend a few hundred dollars on a vaccine than talk to their daughters about responsible sexual practices (or, God forbid, abstinence).

Now comes news that 2006 was also the beginning of a jump in teen pregnancies. I wonder how much more teen pregnancy rates (and AIDS infection rates, for that matter) will increase...

http://www.judicialwatch.org/gardasil

Judicial Watch Investigates Side-Effects of HPV Vaccine

Wed, 05/14/2008 - 14:05 — gstasiewicz "The FDA adverse event reports on the HPV vaccine read like a catalog of horrors. Any state or local government now beset by Merck’s lobbying campaigns to mandate this HPV vaccine for young girls ought to take a look at these adverse health reports."
-Tom Fitton

On June 8, 2006, the Food and Drug Administration (FDA) approved the drug Gardasil. Gardasil is a vaccine against certain types of human papillomavirus (HPV) which is the primary cause of cervical cancer in women.

• Several state and local governments have proposed requiring the vaccine for school girls entering the 6th grade.
• Gardasil is approved for girls as young as nine years old, despite the fact that the youngest girls participating in clinical trials were 11-12 years old.
• A recent study, published in the New England Journal of Medicine, also questioned the general effectiveness of Gardasil. Additionally, there has not been a chance to study long term side effects of the vaccine.

Judicial Watch, concerned about the rush to market and mandate a drug with possible serious adverse effects, filed its first Freedom of Information Act (FOIA) request on May 9, 2007, and received 1,637 adverse event reports on May 15, 2007. These reports are submitted to the Vaccine Adverse Event Reporting System (VAERS) and used by the FDA to monitor the safety of vaccines.

On August 20, 2007 Judicial Watch filed a request for updated adverse event reports and received 1,824 reports on September, 13 2007. Judicial Watch then filed a complaint against the FDA on October 3, 2007 for failing to fully respond to the May 9, 2007 FOIA request.

Judicial Watch has posted links to the adverse event reports below and continues to monitor VAERS reports submitted to the FDA in relation to Gardasil.

Special Reports

• Judicial Watch Special Report: Examining the FDA's HPV Vaccine Records - June 30, 2008
• Examining the FDA's HPV Vaccine Records - Appendices - June 30, 2008

Documents Uncovered

• Vaccine Adverse Effects Report System (VAERS) serious effects report from January 1, 2008 to June 10, 2008 - June 30, 2008
• Vaccine Adverse Effects Report System (VAERS) cumulative deaths report - June 30, 2008
• Vaccine Adverse Effects Report System (VAERS) reports on Guillane-Barre Syndrome, spontaneous abortions, and all life-threatening cases from 2008 - June 30, 2008
• Vaccine Adverse Effects Report System (VAERS) cumulative Gardasil adverse effects report (Warning, this is a very large file) - June 30, 2008
• Merck's application to the FDA to patent the Gardasil vaccine - February 22, 2008
• Merck's report to the FDA giving the details of Gardasil and its clinical test results - February 22, 2008
• A transcript of the Vaccines and Related Biological Products Advisory Committee's meeting to discuss Gardasil - February 22, 2008
• Document from the FDA giving a determination of Regulatory Review Period for Purposes of Patent Extension for Gardasil - February 22, 2008
• Gardasil Related Deaths Reported to VAERS as of September 7, 2007
• Gardasil Related Deaths Reported to VAERS as of May 11, 2007
• Vaccine Adverse Event Reporting System (VAERS) Reports as of September 7, 2007
• Vaccine Adverse Event Reporting System (VAERS) Reports as of May 11, 2007

Legal Documents

• Judicial Watch complaint against the FDA

Press Releases

• Judicial Watch Uncovers New FDA Records Detailing Ten New Deaths & 140 “Serious” Adverse Events Related to Gardasil (June 30, 2008)
• Judicial Watch Uncovers New FDA Records Detailing Deaths in 1,824 Adverse Reaction Reports Related to HPV Vaccine (October 4, 2007)
• Judicial Watch Uncovers Three Deaths Relating to HPV (May 3, 2007)

News Stories, Reports and Informational Links

• New England Journal of Medicine
  • Quadrivalent Vaccine against Human Papillomavirus to Prevent High-Grade Cervical Lesions
• Guide to State Legislation About Mandatory HPV Vaccination

* * *
http://www.medpagetoday.com/InfectiousDisease/PublicHealth/12364

Teen Birth Rate in U.S. Rises

By Kristina Fiore, Staff Writer, MedPage Today
Published: January 07, 2009

HYATTSVILLE, Md., Jan. 7 -- The birth rate among girls ages 15 to 19 jumped 3% in 2006, increasing for the first time in 15 years, according to the CDC's National Center for Health Statistics.

The 2006 rate was 41.9 per 1,000 girls in that age group, up from 40.5 in 2005, Stephanie Ventura, M.A., of the CDC, and colleagues reported in the Jan. 7 issue of National Vital Statistics Reports.

Significant increases in teen births were observed in 26 states, the researchers said, with the highest rates in the South and Southwest.

"The fact that we have 26 states with an increase in one year is noteworthy because it takes a lot for state-specific rates to change in one year," Ventura said. "Those changes are not usually statistically significant."

The highest teen birth rates occurred in Mississippi (68.4 per 1,000 girls), followed by New Mexico (64.1) and Texas (63.1).

The lowest rates occurred in the Northeast, led by New Hampshire (18.7 per 1,000 girls), Vermont (20.8) and Massachusetts (21.3).

Only North Dakota, Rhode Island, and New York saw a decrease in teen birth rates between 2005 and 2006.

Researchers said the teen birth rate declined 34% between 1991 and 2005, with steeper decreases between 1994 and 2003. Decreases were about 1% a year in 2004 and 2005.

"[The slowdown] might have been an early warning sign that the decrease was coming to a halt, at least temporarily," Ventura said. "This year's increase might be just a further reflection of that."

Ventura said the data imply that previous messages about teen pregnancy may "need to be fine-tuned," as "today's youth have different attitudes towards pregnancy," pointing to examples such as the Massachusetts high school students who took part in a "pregnancy pact" and an increasing number of young celebrities becoming mothers.

She added that it's hard to speculate whether the trend will continue.

Birth rates did decrease among the youngest teens -- those ages 10 to 14 -- falling to 0.6 births per 1,000 in 2006 from 0.7 per 1,000 in 2005.

The greatest increase was seen among the oldest teens, ages 18 to 19, with a 4% jump over last year. In the 15- to 17-year-old group, there was a 3% increase.

When broken down by demographics, rates of teen births were highest among non-Hispanic black teens, with a 5% increase from 2005.

Teenagers may be mirroring to a degree what's going on in the rest of the population. Birth rates increased among women in nearly all age groups, especially among those ages 20 to 24 and 40 to 44, the researchers said.

The total number of births in the U.S. was 3% higher in 2006 than in 2005 -- the largest single-year increase since 1989-1990.

And the number of births in 2006 (approximately 4.3 million) was the largest since 1961, according to the researchers.

Rates among women ages 20 to 24 jumped 4% from 2005, after a downward trend between 1990 and 2004.

Women ages 40 to 44 saw a 3% increase in birth rates year over year, with the rate for this age group more than doubling since 1981, the researchers said.

And for the oldest mothers -- those 50 and up -- birth rates jumped 18%, to 494 in 2006 from 417 in 2005.

Ventura said most of these are multiple births, as older women turn to assisted reproductive technologies (ART) to become pregnant.

Joyce A. Martin, M.P.H., of the CDC, a co-author of the report, said that data on multiple birth rates was particularly important, as the twin rate did not change for the second year in a row, and the triplet rate declined significantly.

"This is important because these are such high-risk births," she said. "This may be related to the decreased transfer of eggs in the ART process."

She added that in the late 1990s, the Society for Reproductive Medicine issued guidelines calling for a reduction in the number of embryos transferred with the aim of reducing the number of multiple births.

Dr. Martin said the stabilizing of the twin birth rate was "a bit of a surprise because for some years after these recommendations were made, twin rates did continue to go up. Only in the last couple years did they start to stall."

http://www.cleanwateraction.org/publication/epa-sends-big-stone-ii-coal-plant-back-drawing-board

EPA Sends Big Stone II Coal Plant Back To Drawing Board

Less than three days after the Bush Administration left office, the Environmental Protection Agency (EPA) has overturned the State of South Dakota's approval of the massive BigStone II coal-fired power plant. The EPA's decision comes after the state failed to require state-of-the-art pollution controls for the coal plant that would address concerns about harmful soot, smog and global warming pollution.

EPA decision on Big Stone II, part 1 (pdf, 2.12 MB)

EPA decision on Big Stone II, part 2 (pdf, 2.65 MB)

Nothing will change.

http://online.wsj.com/article/SB123267335720408593.html?mod=dist_smartbrief

...or at least, informed.

http://news.yahoo.com/s/nm/20090122/hl_nm/us_drugs_payments;_ylt=Ai4oN18K7bEsiJNxeFjuMCgQ.3QA

Gifts to doctors must be disclosed under bill

WASHINGTON (Reuters) – Drug and medical device manufacturers would need to publicly disclose all doctor payments and gifts exceeding $100 per year under U.S. legislation unveiled on Thursday.

Companies would face penalties as high as $1 million for knowingly failing to report the payments if the bill by Iowa Republican Sen. Charles Grassley and Wisconsin Democrat Herb Kohl becomes law.

The effort is meant to shine light on the industry's lavish gifts to doctors, which range from pricey dinners to golf vacations, as well as consulting and speaking fees.

Critics have said the payments may skew doctors' decision-making.

"The goal of our legislation is to lay it all out, make the information available for everyone to see, and let people make their own judgments about what the relationships mean or don't mean," Grassley said in a statement.

The information would be posted online for public viewing, the senators said.

Kohl said he was confident the legislation, called the Physician Payment Sunshine Act, would pass in the current Democratic-led Congress.

A previous version did not advance in the last congressional session. It required public reporting only if payments topped $500 per year.

Drug and medical device makers supported the earlier version and said on Thursday they were reviewing the new measure.

Pfizer Inc said paid collaborations between doctors and drugmakers "lead to valuable scientific innovations and improved patient care."

"We agree with the senators that sharing this information publicly in a simple and uniform manner is the best way to provide a complete picture," a Pfizer statement said.

Some manufacturers are moving ahead with voluntary efforts. Eli Lilly & Co will begin disclosing physician payment information later this year.

Medical device makers believe disclosures should provide "meaningful information ... in an appropriate context," said Stephen Ubl, president of industry group AdvaMed.

A voluntary device industry code of ethics prohibits companies from providing entertainment or recreation for doctors, AdvaMed said.

Grassley said he is considering if reporting requirements should also apply to industry payments to medical organizations, hospitals, pharmacy benefit managers, pharmacists and pharmacies, continuing medical education groups and medical schools.

Kohl chairs the Senate Special Committee on Aging and Grassley is the highest-ranking Republican on the Senate Finance Committee.

(Reporting by Lisa Richwine; Editing by Richard Chang and Carol Bishopric)

File this under "no ****, Sherlock."

http://news.yahoo.com/s/nm/20090122/hl_nm/us_fda_safety;_ylt=As3bEJ89eZKEKCaVpLBleyEQ.3QA

Agency questions FDA ability to protect public

Thu Jan 22, 6:34 pm ET

WASHINGTON (Reuters) – The U.S. agency responsible for keeping the public safe from harmful drugs and foods was added to a list of "high-risk" areas of the federal government because it may not be able to adequately do its job, the Government Accountability Office said on Thursday.

The GAO said the U.S. Food and Drug Administration (FDA) was being hampered by globalization, more complex products and laws that have made it more difficult for the FDA to ensure the safety of pharmaceuticals, biologic drugs and medical devices.

The GAO releases this list at the start of each new Congress to help lawmakers set priorities.

The Institute of Medicine and advocacy groups have noted challenges to the FDA's ability to keep dangerous and ineffective products off the U.S. market. The FDA itself has acknowledged that it needs retooling.

"We need your partnership to reshape the agency and to provide us with the resources and legislative authorities necessary to support our work," Acting FDA Commissioner Dr. Frank Torti told members of Congress in a statement dated January 21.

In response to the GAO report, FDA spokeswoman Karen Riley said, "Ensuring that the food and the medical products Americans use are safe is among the highest priorities of the FDA."

GAO investigators said the FDA needs to have better data on its inspections of facilities in other countries and conduct more inspections.

It also must "more systemically review the claims made in drug advertising and promotional material, and ensure that drug sponsors accurately report clinical trial results."

The GAO updated list is on its website at http://www.gao.gov/products/GAO-09-271

(Reporting by Susan Heavey, editing by Maureen Bavdek, Toni Reinhold)

This is what happens when one huge and poorly run factory makes components to all of your food. Gross.

On the up side, something like 7% of kids are allergic to peanuts, so they weren't eating this stuff.

http://www.reuters.com/article/healthNews/idUSTRE50K77120090121

FDA says Georgia plant is sole salmonella source

By Will Dunham

WASHINGTON (Reuters) - The sole source of the U.S. salmonella outbreak involving contaminated peanut butter appears to be the Peanut Corp of America's Blakely, Georgia processing facility, federal officials said on Wednesday.

More than 125 products including cookies, crackers, ice cream and even some pet food have been recalled in connection with the outbreak, the U.S. Food and Drug Administration said.

Six deaths may be associated with the outbreak, the U.S. Centers for Disease Control and Prevention said. The CDC said at least 486 people from 43 states and one person in Canada have been reported ill from the outbreak of the Salmonella typhimurium strain, with 107 of them being hospitalized.

Stephen Sundlof, director of the FDA's Center for Food Safety and Applied Nutrition, said Connecticut health authorities tested an unopened container of peanut butter from the PCA's Blakely plant and discovered the strain linked to the outbreak of illness.

The fact that the unopened container had the strain indicates contamination did not occur after it was shipped from the facility, Sundlof said. Coupled with previous evidence, Sundlof said authorities believe the Blakely plant is the only source of the outbreak.

"That is our assumption at this point. We will continue to follow up on any leads that point us in a different direction," Sundlof told reporters during a conference call.

The plant is not currently operating, he said.

Sundlof said he expects the number of recalled products to continue to increase.

Among the latest was by NutriSystem Inc, which announced on Wednesday a voluntary recall of its peanut butter granola bar. On Tuesday, PetSmart Inc, the largest U.S. pet-products and services retailer, recalled seven of its Grreat Choice Dog Biscuit products.

General Mills Inc, Kellogg Co and other companies also have recalled products.

Authorities say peanut butter sold on grocery store shelves does not appear to be involved.

PCA has recalled peanut butter and peanut paste products manufactured since July at the Blakely plant because of potential Salmonella contamination. Peanut paste is a concentrated product consisting of ground, roasted peanuts.

PCA manufactures peanut butter and peanut paste distributed to food manufacturers to be used as ingredients in commercially produced products. PCA peanut butter also is served in long-term care facilities and cafeterias.

Salmonella can cause abdominal cramping, diarrhea and fever and it can kill the very young and very old. "More cases are being reported every day. The outbreak appears to be ongoing," Dr. Robert Tauxe of the CDC said.

Minnesota authorities previously tested an opened container from the plant, and found the Typhimurium strain.

Sundlof said a federal inspection of the Blakely plant turned up evidence of salmonella on the floor, but not the Typhimurium strain.

"It does indicate that there are problems within the plant because salmonella should not be found there," he said.

(Editing by Julie Steenhuysen and Cynthia Osterman)

Because when you let Big Chemical decide to use the cheapest possible components to make paint, you'll end up with PCBs in your schools--decades after even our poky ol' government has caught on to their toxicity and banned them.

http://www.chicagotribune.com/news/local/chicago/chi-pcb-zonejan22,0,7312688.story

Mystery PCB surfaces in Chicago, baffling researchers

Experts say samples in air could come from old paint

By Michael Hawthorne |Tribune reporter

January 22, 2009

More than three decades after highly toxic PCBs were banned in the United States, an unusual PCB compound has turned up in the air outside several Chicago schools.

Polychlorinated biphenyls are a group of chemicals that once were widely used as coolants and lubricants but were outlawed after studies linked them to cancer, liver and kidney damage and other ailments.

Hundreds of sites around the nation are contaminated with PCBs, which are known as persistent chemicals because they don't break down in the environment and can build up in people and animals. PCBs move easily among land, water and air, and scientists know several of the chemicals tend to be present in the air Chicagoans breathe.

But a study by University of Iowa researchers published late last year in the journal Environmental Science & Technology is the first to detect PCB-11 in air samples.

They were surprised to find it because PCB-11 isn't a chemical that was intentionally manufactured and marketed.

"We might have done a pretty good job shutting down direct sources of PCBs," said Keri Hornbuckle, a civil and environmental engineering professor who oversaw the study. "But this shows we aren't doing enough to shut down what's still out there."

The researchers speculated that the concentrations detected in the air in multiple Chicago locations could be coming from old paint, as other research has found the compound in wastewater from factories that produce yellow pigment.

Or, they said, it could be a previously unknown pollutant in smokestack emissions produced when paint is manufactured. The molecular structure of PCB-11 is similar to a chemical still used in yellow pigment, according to the study.

As part of a larger project examining PCBs in the Chicago area, Hornbuckle and her colleagues mounted air monitors atop two vans that provide medical services in low-income neighborhoods. Samples were collected outside nearly 40 schools.

The team found concentrations of several PCBs in the air, as expected, but they were surprised to find levels of PCB-11 in virtually every sample.

Most of the schools are in old industrial neighborhoods on the Northwest, West and Southeast Sides. The highest concentrations were found outside Casals Elementary in Humboldt Park and St. Gall Elementary in Gage Park.

Representatives from the Chicago Public Schools and the Chicago archdiocese said they were unaware of the study. Officials at the Illinois Environmental Protection Agency said they would need to conduct more air sampling and review scientific papers about PCB-11 before deciding whether to investigate further.

PCBs were dumped for years with little or no regulation and contaminated dozens of waterways around the country, including Waukegan Harbor in Illinois, the Grand Calumet River in northwest Indiana and Green Bay in Wisconsin. Scientists have known for years that PCBs accumulate in the fatty tissues of fish, leading to advisories throughout the Great Lakes region to limit eating most freshwater species.

Less is known about the potential health effects of airborne exposure to the chemicals, though steady levels of PCBs in fish can be attributed in part to pollution falling from the air into waterways.

"We haven't paid a lot of attention to this particular PCB before," said Victoria Persky, an epidemiologist at the University of Illinois at Chicago who helped arrange the testing methods the Iowa researchers used. "We need to see more data before deciding whether we should be alarmed."

More than 50 factories in Chicago list paint and pigment production as part of their manufacturing processes, but none report releasing PCBs into the air, adding to the mystery of where the PCB-11 is coming from.

mhawthorne@tribune.com